1. Pink Sheet

US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation

 
• By Derrick Gingery

Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.

Drugs and judge's gavel
A court ruling denies FDA from awarding orphan exclusivity for population subsets, such as adults or children. • Source: Shutterstock

Catalyst Pharmaceuticals, Inc.’s court victory, which scrambled the US Food and Drug Administration’s orphan drug exclusivity policy, could be undone in upcoming user fee reauthorization legislation.

A federal appeals court in September 2021 ruled that the FDA should withdraw approval of Jacobus Pharmaceutical Co. Inc’s...

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